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TrioTest CD4 FITC /CD8 PE/CD3 PerCP Kit
EUDAMEDClass C (EU MDR)
Ref 8930012CEModel 50T,100T
Identity
- Device Name
- TrioTest CD4 FITC /CD8 PE/CD3 PerCP Kit EUDAMED
- Model / Reference
- 50T,100T EUDAMED8930012CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974501891044 EUDAMED
- Basic UDI-DI
- 69745018900C002401WA EUDAMED
- EMDN Code
- W0103080101 ANTIBODIES FOR B AND T-CELL SUBTYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
TrioTest CD4 FITC /CD8 PE/CD3 PerCP Kit by Agilent Biosciences (Hangzhou) Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69745018900C002401WA | Class C | Active |
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Manufacturer
- Manufacturer
- Agilent Biosciences (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013066
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED 8f3a705c-7e16-47f7-8f80-1293c27de3d2 61 fields · synced Jun 18, 2026